1 Start with a strategy

The first crucial step is to know what your product does and doesn’t do, in order to correctly categorize it. This may sound obvious, but it’s so obvious it’s also easy to overlook. The product’s categorization – and corresponding risk classification – is an early and important signpost for navigating through regulatory compliance.

It’s also important to identify where the product will be put on the market. Different regions implement different medical device legislation. On top of that, although a region (such as the EU) might be covered by a single piece of legislation (the EU’s MDR) individual states within that region can have their own additional requirements. 

Knowing where to find the relevant information for each country can be a complex and time-consuming process. That’s why it’s important to have a regulatory strategy in place.

2 Make the right translations 

Bringing a medical device to market in a multi-language region like the EU means translating product documentation and labels into the correct local languages. Not only that, instructions also need to be available in both professional and plain language versions following the national requirements.

Up until now, it was down to companies to locate the relevant information themselves. However, guidance on translations from the Medical Device Coordination Group (MDCG) has recently been released to medical device manufacturers. The new guidance provides better guidelines for language requirements for both the MDR and the In Vitro Diagnostic Regulation.

Take Software as a Medical Device (SaMD), for example. In the Netherlands, the label and instructions for use (IFU) must be available in Dutch for patients or lay users, and English may be used where it concerns an IFU for medical professionals. In Belgium, the label, IFU and user interface should be available in French, Dutch and German language due to the multilingual nature of the country. 

On top of that, some European languages contain nuances that vary per language, requiring localization of the content instead of straight-up translation to maintain clinical validity. It takes time, technical understanding, and translation services with a specialism in healthcare to get translations correct and compliant. 

Here at Peercode, our golden rule for translations of external-facing text within the software is to run them by a native speaker. Like product testing, the native speakers perform a variety of tasks on the SaMD to check that everything is comprehensible, and understandable within the context of the software. They also check external-facing instructions.

3 Understand each market 

With so many European markets falling under the MDR – each with their own unique requirements –  it can be difficult to navigate through country-specific regulations – especially when many of those may not even apply to your product. 

The easiest way to maintain oversight and control over multiple regulations, is to create a matrix of requirements. This enables you to track action items related to compliance across your chosen markets. Every company is different, but one tried and tested approach is to bring a medical device to a few related markets, and then scale it to others.

Peercode’s telemonitoring software – Atris – was initially released on the Dutch medtech market. A German professor witnessed its use in a Dutch hospital, and asked if it could be brought to Germany. Although possible, it couldn’t happen immediately, since the market requirements for Germany had to be fulfilled first. Translations need to be checked and verified to ensure everything is properly translated for the intended market. 

Certain EU member states and participants in the single market impose extra registration steps for class IIa, class IIb, and class III medical devices. Manufacturers, including those outside the EU, might have to submit a registration form and provide information online before placing products in the market. This typically involves uploading a localized label, instructions for use, Declaration of Conformity, and the CE certificate. Additional registration requirements may also exist for local Authorized Representatives and manufacturers. The expectation is that once the European Database on Medical Devices (EUDAMED) is fully implemented, many of these country-specific registration requirements will be removed.

This is further complicated by constantly changing regulations. A good example is the UK’s exit from the EU. This left unanswered questions around the use of a CE mark on medical device products in that particular market. Ensuring a product adheres to the latest version of a country’s requirements takes ongoing research and investigation. As such, it is important to stay informed by regularly checking the websites of the Competent Authorities in each country for specific requirements.

Some medtech companies choose to go for US Food And Drug Administration (FDA) clearance first, since it is considered to be more straightforward to achieve when compared to MDR compliance. The great thing about this approach is that much of the work done for the technical file needed for FDA clearance can be adapted and reused for compliance with the EU’s MDR.

Your guide through the legislative landscape

Here at Peercode Regulatory Consultancy, we use our experience and expertise in regulatory compliance to help medtech companies to ensure compliance with multiple medical device markets. 

From getting the correct translations for different markets to understanding how to put together a robust and MDR-compliant quality management system (QMS), we’re your guide through the legislative landscape both in preparation for going to market, and also post market. Ultimately, we help to ensure you get medical device compliance right first time – saving you time and money.

Speak to a regulatory specialist today.